A Phase IV, Randomized, Open-label, Parallel-arm, Comparative and Forced- Titration Study to Compare the Efficacy and Safety of Rosuvastatin Versus Simvastatin in Patients With Type 2 DM and Dyslipidemia
Sponsor study identifier
interventional
90
1 country
2
Study Start
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2007
Actual (reported)Study Completion
July 2007
Actual (reported)This is a phase IV, randomized, open-label, parallel-arm, comparative and forced- titration study to compare the efficacy and safety of rosuvastatin versus simvastatin in patients with type 2 DM and dyslipidemia. When comparing the efficacy of rosuvastatin 20 mg with simvastatin 40 mg for the treatment of type 2 DM with dyslipidemia, rosuvastatin 20 mg is superior to simvastatin 40 mg in achieving the combined goal of LDL-C (\<100 mg/dL) and non-HDL-C (\<130 mg/dL).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2007
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
July 2007
Actual (reported)July 2007
Actual (reported)July 24, 2007
Actual (reported)July 25, 2007
Actual (reported)The percentage of patients achieving the combined treatment goal of LDL-C < 100mg/dl and non-HDL-C < 130 mg/dl at week 12 with rosuvastatin treatment compared with simvastatin treatment
12 weeks
Achieving the combined treatment goal of LDL-C (<100 mg/dL) and non-HDL-C (130 mg/dL) at week 4;
4 weeks
Percentage of patients achieving the LDL-C goal of <100 mg/dL at week 4 and week 12;
12 weeks
Percentage of patients achieving the LDL-C goal of <70 mg/dL at Week;The mean percent change from baseline in lipid profile at week 4 and week 12;
12 weeks
10 mg rosuvastatin for 4 weeks followed by 20 m rosuvastatin for another 8 weeks
20 mg simvastatin for 4 weeks followed by 40 mg simvastatin for another 8 weeks
10 mg rosuvastatin for 4 weeks followed by rosuvastatin or another 12 weeks
20 mg simvastatin for 4 weeks followed by 40 mg simvastatin for another 8 weeks
Taichung Veterans General Hospital
Taichung, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Wu TH, Lee IT, Ho LT, Sheu WH, Hwu CM. Combined lipid goal attainment in patients with type 2 diabetes and dyslipidemia: A head-to-head comparative trial of statins. J Chin Med Assoc. 2022 Aug 1;85(8):831-838. doi: 10.1097/JCMA.0000000000000765. Epub 2022 Jun 20.
Chii-Min Hwu, MD
Taipei Veterans General Hospital, Taiwan
Wayne H Sheu, MD,phD
Taichung Veterans General Hospital
90 participants (actual enrollment reported by the registry).
First Submitted
July 24, 2007
First Posted
July 25, 2007
Study Start
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
July 2007
Actual (reported)Study Completion
July 2007
Actual (reported)Last Updated
December 6, 2011
Record last verified: 2011-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: